BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2180943 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05678
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2010
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT'S PUMP AND CATHETER WERE RECEIVED BY THE MANUFACTURER. LATER ON (B)(6) 2011, ADDITIONAL INFO RECEIVED FROM THE HCP (HEALTH CARE PROVIDER) INDICATED THAT THE PT EXPERIENCED INCREASED SPASTICITY. THE PT WAS HOSPITALIZED. THE CAUSE OF THE EVENT/ISSUE WAS "UNKNOWN", HOWEVER, THE EVENT WAS FURTHER REPORTED TO NOT HAVE BEEN DUE TO DRUG EFFECTS OR DEVICE PROGRAMMING. THE PT RECOVERED WITHOUT SEQUELAE. THE DRUG INFUSED VIA THE PUMP WAS LIORESAL 2000MCG/ML AT 1600 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R CATHETER: MODEL 8731, LOT# B005906N28| IMPLANTED:| EXPLANTED: